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U.S. Department of Health and Human Services

Class 2 Device Recall LMA Unique

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 Class 2 Device Recall LMA Uniquesee related information
Date Initiated by FirmJune 18, 2003
Date PostedJuly 29, 2003
Recall Status1 Terminated 3 on November 03, 2003
Recall NumberZ-1053-03
Recall Event ID 26577
Product Classification Airway, Oropharyngeal, Anesthesiology - Product Code CAE
ProductLMA- Unique Laryngeal Mask Airway Size 4, Catalog No. 12140, Lot FH041202 Size 4, Catalog No. 12150, Lot FJ021202
Code Information Lots FH041202 and FJ021202
FEI Number 3001338204
Recalling Firm/
Manufacturer		 LMA North America Inc
9360 Towne Centre Dr
San Diego CA 921213030
For Additional Information ContactMs. Cindy Luchetti
858-622-5669
Manufacturer Reason
for Recall		Sterility cannot be assured
FDA Determined
Cause 2		Other
ActionRecall letters were issued on June 18, 2003 to customers. It requests return of product and included a request to fax back inventory description.
Quantity in Commerce2,579
DistributionNationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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